MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS 5X20; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number M003124FPP0

Device Problem Activation Failure (3270)

Patient Problem Perforation of Vessels (2135)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

The device remains implanted in patient.

Event Description

It was reported that during the procedure the stent was unable to open after deployment.Therefore, a balloon exchange to expand the stent was performed which causing a perforation of the middle cerebral vessel.In addition,decompressive craniectomy was performed as a medical intervention due to the reported event.No further information is available for now.

Manufacturer Narrative

Adverse event/product problem: changed to ¿product problem¿ based on additional information received on 3-sep-2019.Outcomes attributed to ae: removed selection for ¿other serious (important medical events)¿ and ¿required intervention to prevent permanent impairment/damage (devices)¿ based on additional information received on 3-sep-2019.Expiration date: added.Type of reportable event: changed to ¿malfunction¿ based on additional information received on 3-sep-2019.Manufacturing date: added.Patient code: removed ¿vessels, perforation of¿ based on additional information received on 3-sep-2019.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.Additional information stated that the patients anatomy was of medium tortuousity.The flow diverter failed to open distally and balloon exchange was required to expand.It is probable that the tortuousity of the anatomy may have caused difficulties in deploying the stent and subsequent failure to fully open the stent.Therefore, a probable cause of procedural factors will be assigned to the reported event as the issue is associated with a product that meets the design and manufacture specifications and was used in according with the dfu (direction for use) but due to procedural and/or anatomical factors during use, the product performance was limited.

Event Description

It was reported that during the procedure the stent was unable to open after deployment.Therefore, a balloon exchange to expand the stent was performed which causing a perforation of the middle cerebral vessel.In addition, decompressive craniectomy was performed as a medical intervention due to the reported event.No further information is available for now.

• Brand Name: SURPASS 5X20
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8877123
• MDR Text Key: 153802249
• Report Number: 3008881809-2019-00234
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: M003124FPP0
• Device Lot Number: 19629692
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention